Trial Outcomes & Findings for The Immunogenicity of Simultaneous Administration of Quadrivalent Influenza Vaccine and 23-valent Pneumococcal Vaccine (NCT NCT02592486)
NCT ID: NCT02592486
Last Updated: 2019-01-31
Results Overview
The primary endpoint was the number of patients with positive antibody responses (≥2-fold increase in IgG concentrations 4-6 weeks after PPSV23 vaccination) in serotype 23F of the pneumococcal antibody.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
162 participants
Primary outcome timeframe
1month after the dose of PPV23
Results posted on
2019-01-31
Participant Flow
Participant milestones
| Measure |
Simultaneous Administration Group
The subjects receive injections of pneumococcal vaccine and influenza vaccine simultaneously. We use commercially available PPV23 (Pneumovax NP®, MSDKK, Tokyo, Japan) containing 25 μg each of 23 capsular polysaccharide types. We use Fluvic HA syringe® (Handai Biken Ltd, Osaka, Japan), quadrivalent influenza vaccine (0.5ml) of 2015/2016 season.
Simultaneous administration of Pneumovax NP® and Fluvic HA syringe®: Injections of pneumococcal vaccine and influenza vaccine simultaneously.
|
Sequential Administration Group
The subjects receive injections of pneumococcal vaccine 2 weeks after the injection of the influenza vaccine. We use commercially available PPV23 (Pneumovax NP®, MSDKK, Tokyo, Japan) containing 25 μg each of 23 capsular polysaccharide types. We use Fluvic HA syringe® (Handai Biken Ltd, Osaka, Japan), quadrivalent influenza vaccine (0.5ml) of 2015/2016.
Sequential administration of Pneumovax NP® and Fluvic HA syringe®: Injections of pneumococcal vaccine 2 weeks after the injection of the influenza vaccine.
|
|---|---|---|
|
Overall Study
STARTED
|
81
|
81
|
|
Overall Study
COMPLETED
|
81
|
76
|
|
Overall Study
NOT COMPLETED
|
0
|
5
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The Immunogenicity of Simultaneous Administration of Quadrivalent Influenza Vaccine and 23-valent Pneumococcal Vaccine
Baseline characteristics by cohort
| Measure |
Simultaneous Administration Group
n=81 Participants
The subjects receive injections of pneumococcal vaccine and influenza vaccine simultaneously. We use commercially available PPV23 (Pneumovax NP®, MSDKK, Tokyo, Japan) containing 25 μg each of 23 capsular polysaccharide types. We use Fluvic HA syringe® (Handai Biken Ltd, Osaka, Japan), quadrivalent influenza vaccine (0.5ml) of 2015/2016 season.
Simultaneous administration of Pneumovax NP® and Fluvic HA syringe®: Injections of pneumococcal vaccine and influenza vaccine simultaneously.
|
Sequential Administration Group
n=80 Participants
The subjects receive injections of pneumococcal vaccine 2 weeks after the injection of the influenza vaccine. We use commercially available PPV23 (Pneumovax NP®, MSDKK, Tokyo, Japan) containing 25 μg each of 23 capsular polysaccharide types. We use Fluvic HA syringe® (Handai Biken Ltd, Osaka, Japan), quadrivalent influenza vaccine (0.5ml) of 2015/2016.
Sequential administration of Pneumovax NP® and Fluvic HA syringe®: Injections of pneumococcal vaccine 2 weeks after the injection of the influenza vaccine.
|
Total
n=161 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
71.0 years
STANDARD_DEVIATION 5.1 • n=5 Participants
|
70.2 years
STANDARD_DEVIATION 4.1 • n=7 Participants
|
70.6 years
STANDARD_DEVIATION 4.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
33 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
64 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
48 Participants
n=5 Participants
|
49 Participants
n=7 Participants
|
97 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1month after the dose of PPV23Population: In the sequential group, 5 patients were excluded from primary analysis because of the reasons below. 1 patient: eligibility error, 1 patient: lost to follow-up (patient's decision), 3 patient: discontinued intervention (1 patient: fever, 2 patients: patient's decision
The primary endpoint was the number of patients with positive antibody responses (≥2-fold increase in IgG concentrations 4-6 weeks after PPSV23 vaccination) in serotype 23F of the pneumococcal antibody.
Outcome measures
| Measure |
Simultaneous Administration Group
n=81 Participants
The subjects receive injections of pneumococcal vaccine and influenza vaccine simultaneously. We use commercially available PPV23 (Pneumovax NP®, MSDKK, Tokyo, Japan) containing 25 μg each of 23 capsular polysaccharide types. We use Fluvic HA syringe® (Handai Biken Ltd, Osaka, Japan), quadrivalent influenza vaccine (0.5ml) of 2015/2016 season.
Simultaneous administration of Pneumovax NP® and Fluvic HA syringe®: Injections of pneumococcal vaccine and influenza vaccine simultaneously.
|
Sequential Administration Group
n=76 Participants
The subjects receive injections of pneumococcal vaccine 2 weeks after the injection of the influenza vaccine. We use commercially available PPV23 (Pneumovax NP®, MSDKK, Tokyo, Japan) containing 25 μg each of 23 capsular polysaccharide types. We use Fluvic HA syringe® (Handai Biken Ltd, Osaka, Japan), quadrivalent influenza vaccine (0.5ml) of 2015/2016.
Sequential administration of Pneumovax NP® and Fluvic HA syringe®: Injections of pneumococcal vaccine 2 weeks after the injection of the influenza vaccine.
|
|---|---|---|
|
The Number of Patients With Positive Antibody Response in Serotype 23F of Pneumococcal Antibody.
|
63 Participants
|
59 Participants
|
SECONDARY outcome
Timeframe: 4 to 6 weeks after vaccination (P1), 24 weeks to 27 weeks after vaccination (P2)Population: Immunogenicity was assessed in patients who received the allocated intervention (i.e., received at least 1 dose of the study vaccine), and had a blood sample taken within the planned time period.intervention (1 patient: fever, 2 patients: patient's decision
Positive antibody response was defined as ≥2-fold increase in IgG concentrations 4-6 weeks after PPSV23 vaccination in respective serotypes of the pneumococcal antibody.
Outcome measures
| Measure |
Simultaneous Administration Group
n=81 Participants
The subjects receive injections of pneumococcal vaccine and influenza vaccine simultaneously. We use commercially available PPV23 (Pneumovax NP®, MSDKK, Tokyo, Japan) containing 25 μg each of 23 capsular polysaccharide types. We use Fluvic HA syringe® (Handai Biken Ltd, Osaka, Japan), quadrivalent influenza vaccine (0.5ml) of 2015/2016 season.
Simultaneous administration of Pneumovax NP® and Fluvic HA syringe®: Injections of pneumococcal vaccine and influenza vaccine simultaneously.
|
Sequential Administration Group
n=76 Participants
The subjects receive injections of pneumococcal vaccine 2 weeks after the injection of the influenza vaccine. We use commercially available PPV23 (Pneumovax NP®, MSDKK, Tokyo, Japan) containing 25 μg each of 23 capsular polysaccharide types. We use Fluvic HA syringe® (Handai Biken Ltd, Osaka, Japan), quadrivalent influenza vaccine (0.5ml) of 2015/2016.
Sequential administration of Pneumovax NP® and Fluvic HA syringe®: Injections of pneumococcal vaccine 2 weeks after the injection of the influenza vaccine.
|
|---|---|---|
|
The Number of Patients With Positive Antibody Response in Serotype 3, 4, 6B, 1 4 and 19A of Pneumococcal Antibody.
4-6 weeks after vaccination 3
|
56 Participants
|
52 Participants
|
|
The Number of Patients With Positive Antibody Response in Serotype 3, 4, 6B, 1 4 and 19A of Pneumococcal Antibody.
4-6 weeks after vaccination 4
|
54 Participants
|
66 Participants
|
|
The Number of Patients With Positive Antibody Response in Serotype 3, 4, 6B, 1 4 and 19A of Pneumococcal Antibody.
4-6 weeks after vaccination 6B
|
59 Participants
|
63 Participants
|
|
The Number of Patients With Positive Antibody Response in Serotype 3, 4, 6B, 1 4 and 19A of Pneumococcal Antibody.
4-6 weeks after vaccination 14
|
49 Participants
|
67 Participants
|
|
The Number of Patients With Positive Antibody Response in Serotype 3, 4, 6B, 1 4 and 19A of Pneumococcal Antibody.
4-6 weeks after vaccination 19A
|
61 Participants
|
59 Participants
|
|
The Number of Patients With Positive Antibody Response in Serotype 3, 4, 6B, 1 4 and 19A of Pneumococcal Antibody.
24-27 weeks after vaccination 3
|
59 Participants
|
51 Participants
|
|
The Number of Patients With Positive Antibody Response in Serotype 3, 4, 6B, 1 4 and 19A of Pneumococcal Antibody.
24-27 weeks after vaccination 4
|
58 Participants
|
67 Participants
|
|
The Number of Patients With Positive Antibody Response in Serotype 3, 4, 6B, 1 4 and 19A of Pneumococcal Antibody.
24-27 weeks after vaccination 6B
|
66 Participants
|
63 Participants
|
|
The Number of Patients With Positive Antibody Response in Serotype 3, 4, 6B, 1 4 and 19A of Pneumococcal Antibody.
24-27 weeks after vaccination 14
|
59 Participants
|
66 Participants
|
|
The Number of Patients With Positive Antibody Response in Serotype 3, 4, 6B, 1 4 and 19A of Pneumococcal Antibody.
24-27 weeks after vaccination 19A
|
67 Participants
|
63 Participants
|
SECONDARY outcome
Timeframe: Before vaccination (at baseline; in designated P0), 4 to 6 weeks after vaccination (P1), 24 weeks to 27 weeks after vaccination (P2)Population: Immunogenicity was assessed in patients who received the allocated intervention (i.e., received at least 1 dose of the study vaccine), and had a blood sample taken within the planned time period.
Pneumococcal IgG concentrations were converted using natural log transformations and presented as a geometric mean concentration.
Outcome measures
| Measure |
Simultaneous Administration Group
n=81 Participants
The subjects receive injections of pneumococcal vaccine and influenza vaccine simultaneously. We use commercially available PPV23 (Pneumovax NP®, MSDKK, Tokyo, Japan) containing 25 μg each of 23 capsular polysaccharide types. We use Fluvic HA syringe® (Handai Biken Ltd, Osaka, Japan), quadrivalent influenza vaccine (0.5ml) of 2015/2016 season.
Simultaneous administration of Pneumovax NP® and Fluvic HA syringe®: Injections of pneumococcal vaccine and influenza vaccine simultaneously.
|
Sequential Administration Group
n=76 Participants
The subjects receive injections of pneumococcal vaccine 2 weeks after the injection of the influenza vaccine. We use commercially available PPV23 (Pneumovax NP®, MSDKK, Tokyo, Japan) containing 25 μg each of 23 capsular polysaccharide types. We use Fluvic HA syringe® (Handai Biken Ltd, Osaka, Japan), quadrivalent influenza vaccine (0.5ml) of 2015/2016.
Sequential administration of Pneumovax NP® and Fluvic HA syringe®: Injections of pneumococcal vaccine 2 weeks after the injection of the influenza vaccine.
|
|---|---|---|
|
The Geometric Mean Concentrations of Specific Antibodies to the 6 Serotypes (23F, 3, 4, 6B 14 and 19A)
Before vaccination 23F
|
0.40 micrograms per milliliter
Interval 0.3 to 0.55
|
0.20 micrograms per milliliter
Interval 0.15 to 0.26
|
|
The Geometric Mean Concentrations of Specific Antibodies to the 6 Serotypes (23F, 3, 4, 6B 14 and 19A)
Before vaccination 3
|
0.07 micrograms per milliliter
Interval 0.06 to 0.09
|
0.07 micrograms per milliliter
Interval 0.06 to 0.08
|
|
The Geometric Mean Concentrations of Specific Antibodies to the 6 Serotypes (23F, 3, 4, 6B 14 and 19A)
Before vaccination 4
|
0.08 micrograms per milliliter
Interval 0.06 to 0.1
|
0.05 micrograms per milliliter
Interval 0.04 to 0.06
|
|
The Geometric Mean Concentrations of Specific Antibodies to the 6 Serotypes (23F, 3, 4, 6B 14 and 19A)
Before vaccination 6B
|
0.24 micrograms per milliliter
Interval 0.18 to 0.31
|
0.14 micrograms per milliliter
Interval 0.11 to 0.18
|
|
The Geometric Mean Concentrations of Specific Antibodies to the 6 Serotypes (23F, 3, 4, 6B 14 and 19A)
Before vaccination 14
|
0.68 micrograms per milliliter
Interval 0.5 to 0.92
|
0.42 micrograms per milliliter
Interval 0.32 to 0.57
|
|
The Geometric Mean Concentrations of Specific Antibodies to the 6 Serotypes (23F, 3, 4, 6B 14 and 19A)
Before vaccination 19A
|
0.72 micrograms per milliliter
Interval 0.55 to 0.94
|
0.49 micrograms per milliliter
Interval 0.38 to 0.64
|
|
The Geometric Mean Concentrations of Specific Antibodies to the 6 Serotypes (23F, 3, 4, 6B 14 and 19A)
4-6 weeks after vaccination 23F
|
2.04 micrograms per milliliter
Interval 1.42 to 2.94
|
1.41 micrograms per milliliter
Interval 0.98 to 2.04
|
|
The Geometric Mean Concentrations of Specific Antibodies to the 6 Serotypes (23F, 3, 4, 6B 14 and 19A)
4-6 weeks after vaccination 3
|
0.24 micrograms per milliliter
Interval 0.19 to 0.31
|
0.21 micrograms per milliliter
Interval 0.17 to 0.27
|
|
The Geometric Mean Concentrations of Specific Antibodies to the 6 Serotypes (23F, 3, 4, 6B 14 and 19A)
4-6 weeks after vaccination 4
|
0.24 micrograms per milliliter
Interval 0.18 to 0.33
|
0.28 micrograms per milliliter
Interval 0.2 to 0.39
|
|
The Geometric Mean Concentrations of Specific Antibodies to the 6 Serotypes (23F, 3, 4, 6B 14 and 19A)
4-6 weeks after vaccination 6B
|
0.96 micrograms per milliliter
Interval 0.69 to 1.32
|
0.96 micrograms per milliliter
Interval 0.67 to 1.37
|
|
The Geometric Mean Concentrations of Specific Antibodies to the 6 Serotypes (23F, 3, 4, 6B 14 and 19A)
4-6 weeks after vaccination 14
|
2.78 micrograms per milliliter
Interval 1.84 to 4.19
|
4.72 micrograms per milliliter
Interval 3.14 to 7.09
|
|
The Geometric Mean Concentrations of Specific Antibodies to the 6 Serotypes (23F, 3, 4, 6B 14 and 19A)
4-6 weeks after vaccination 19A
|
3.74 micrograms per milliliter
Interval 2.69 to 5.19
|
2.92 micrograms per milliliter
Interval 1.98 to 4.23
|
|
The Geometric Mean Concentrations of Specific Antibodies to the 6 Serotypes (23F, 3, 4, 6B 14 and 19A)
24-27 weeks after vaccination 23F
|
2.12 micrograms per milliliter
Interval 1.58 to 2.86
|
1.70 micrograms per milliliter
Interval 1.18 to 2.46
|
|
The Geometric Mean Concentrations of Specific Antibodies to the 6 Serotypes (23F, 3, 4, 6B 14 and 19A)
24-27 weeks after vaccination 3
|
0.26 micrograms per milliliter
Interval 0.21 to 0.34
|
0.24 micrograms per milliliter
Interval 0.19 to 0.31
|
|
The Geometric Mean Concentrations of Specific Antibodies to the 6 Serotypes (23F, 3, 4, 6B 14 and 19A)
24-27 weeks after vaccination 4
|
0.30 micrograms per milliliter
Interval 0.22 to 0.41
|
0.36 micrograms per milliliter
Interval 0.27 to 0.48
|
|
The Geometric Mean Concentrations of Specific Antibodies to the 6 Serotypes (23F, 3, 4, 6B 14 and 19A)
24-27 weeks after vaccination 6B
|
1.18 micrograms per milliliter
Interval 0.88 to 1.57
|
1.29 micrograms per milliliter
Interval 0.91 to 1.82
|
|
The Geometric Mean Concentrations of Specific Antibodies to the 6 Serotypes (23F, 3, 4, 6B 14 and 19A)
24-27 weeks after vaccination 14
|
3.57 micrograms per milliliter
Interval 2.42 to 5.27
|
6.21 micrograms per milliliter
Interval 4.23 to 9.13
|
|
The Geometric Mean Concentrations of Specific Antibodies to the 6 Serotypes (23F, 3, 4, 6B 14 and 19A)
24-27 weeks after vaccination 19A
|
4.61 micrograms per milliliter
Interval 3.47 to 6.11
|
3.38 micrograms per milliliter
Interval 2.47 to 4.63
|
SECONDARY outcome
Timeframe: 4 to 6 weeks after vaccination (I1) and 24 weeks to 27 weeks after vaccination (I2)Population: Immunogenicity was assessed in patients who received the allocated intervention (i.e., received at least 1 dose of the study vaccine), and had a blood sample taken within the planned time period.
Seroprotection rates (post-vaccination titer ≥1:40) were calculated to assess the immunogenicity of influenza vaccination.
Outcome measures
| Measure |
Simultaneous Administration Group
n=81 Participants
The subjects receive injections of pneumococcal vaccine and influenza vaccine simultaneously. We use commercially available PPV23 (Pneumovax NP®, MSDKK, Tokyo, Japan) containing 25 μg each of 23 capsular polysaccharide types. We use Fluvic HA syringe® (Handai Biken Ltd, Osaka, Japan), quadrivalent influenza vaccine (0.5ml) of 2015/2016 season.
Simultaneous administration of Pneumovax NP® and Fluvic HA syringe®: Injections of pneumococcal vaccine and influenza vaccine simultaneously.
|
Sequential Administration Group
n=77 Participants
The subjects receive injections of pneumococcal vaccine 2 weeks after the injection of the influenza vaccine. We use commercially available PPV23 (Pneumovax NP®, MSDKK, Tokyo, Japan) containing 25 μg each of 23 capsular polysaccharide types. We use Fluvic HA syringe® (Handai Biken Ltd, Osaka, Japan), quadrivalent influenza vaccine (0.5ml) of 2015/2016.
Sequential administration of Pneumovax NP® and Fluvic HA syringe®: Injections of pneumococcal vaccine 2 weeks after the injection of the influenza vaccine.
|
|---|---|---|
|
The Number of Patients With Seroprotection Rate in Quadrivalent Influenza Vaccine.
4 to 6 weeks after vaccination : H1N1
|
68 Participants
|
60 Participants
|
|
The Number of Patients With Seroprotection Rate in Quadrivalent Influenza Vaccine.
4 to 6 weeks after vaccination : H3N2
|
66 Participants
|
68 Participants
|
|
The Number of Patients With Seroprotection Rate in Quadrivalent Influenza Vaccine.
4 to 6 weeks after vaccination : B texas
|
33 Participants
|
45 Participants
|
|
The Number of Patients With Seroprotection Rate in Quadrivalent Influenza Vaccine.
4 to 6 weeks after vaccination : B Phuket
|
49 Participants
|
48 Participants
|
|
The Number of Patients With Seroprotection Rate in Quadrivalent Influenza Vaccine.
24 weeks to 27 weeks after vaccination : H1N1
|
41 Participants
|
46 Participants
|
|
The Number of Patients With Seroprotection Rate in Quadrivalent Influenza Vaccine.
24 weeks to 27 weeks after vaccination : H3N2
|
47 Participants
|
44 Participants
|
|
The Number of Patients With Seroprotection Rate in Quadrivalent Influenza Vaccine.
24 weeks to 27 weeks after vaccination : B texas
|
18 Participants
|
11 Participants
|
|
The Number of Patients With Seroprotection Rate in Quadrivalent Influenza Vaccine.
24 weeks to 27 weeks after vaccination : B Phuket
|
24 Participants
|
16 Participants
|
Adverse Events
Simultaneous Administration Group
Serious events: 0 serious events
Other events: 20 other events
Deaths: 0 deaths
Sequential Administration Group
Serious events: 0 serious events
Other events: 31 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Simultaneous Administration Group
n=81 participants at risk
The subjects receive injections of pneumococcal vaccine and influenza vaccine simultaneously. We use commercially available PPV23 (Pneumovax NP®, MSDKK, Tokyo, Japan) containing 25 μg each of 23 capsular polysaccharide types. We use Fluvic HA syringe® (Handai Biken Ltd, Osaka, Japan), quadrivalent influenza vaccine (0.5ml) of 2015/2016 season.
Simultaneous administration of Pneumovax NP® and Fluvic HA syringe®: Injections of pneumococcal vaccine and influenza vaccine simultaneously.
|
Sequential Administration Group
n=79 participants at risk；n=80 participants at risk
The subjects receive injections of pneumococcal vaccine 2 weeks after the injection of the influenza vaccine. We use commercially available PPV23 (Pneumovax NP®, MSDKK, Tokyo, Japan) containing 25 μg each of 23 capsular polysaccharide types. We use Fluvic HA syringe® (Handai Biken Ltd, Osaka, Japan), quadrivalent influenza vaccine (0.5ml) of 2015/2016.
Sequential administration of Pneumovax NP® and Fluvic HA syringe®: Injections of pneumococcal vaccine 2 weeks after the injection of the influenza vaccine.
|
|---|---|---|
|
General disorders
Fatigue
|
11.1%
9/81 • Local reactions at the injection site as well as systemic reactions were monitored for 28 days in the group that received the simultaneous administration, and for 14 days after each injection in the sequential group.
The population in which safety was assessed consisted of participants who received a minimum of 1 dose of the vaccine. In the sequential group, 2 patients were excluded from the evaluation of adverse events because of the reasons below.1 patient: eligibility error, 1 patient: discontinued intervention (patient's decision) Regarding pain of axilla (evaluated only patients who received pneumococcal vaccine), additional 2 patients were excluded because they did not receive pneumococcal vaccine.
|
24.1%
19/79 • Local reactions at the injection site as well as systemic reactions were monitored for 28 days in the group that received the simultaneous administration, and for 14 days after each injection in the sequential group.
The population in which safety was assessed consisted of participants who received a minimum of 1 dose of the vaccine. In the sequential group, 2 patients were excluded from the evaluation of adverse events because of the reasons below.1 patient: eligibility error, 1 patient: discontinued intervention (patient's decision) Regarding pain of axilla (evaluated only patients who received pneumococcal vaccine), additional 2 patients were excluded because they did not receive pneumococcal vaccine.
|
|
Skin and subcutaneous tissue disorders
Joint pain
|
13.6%
11/81 • Local reactions at the injection site as well as systemic reactions were monitored for 28 days in the group that received the simultaneous administration, and for 14 days after each injection in the sequential group.
The population in which safety was assessed consisted of participants who received a minimum of 1 dose of the vaccine. In the sequential group, 2 patients were excluded from the evaluation of adverse events because of the reasons below.1 patient: eligibility error, 1 patient: discontinued intervention (patient's decision) Regarding pain of axilla (evaluated only patients who received pneumococcal vaccine), additional 2 patients were excluded because they did not receive pneumococcal vaccine.
|
13.9%
11/79 • Local reactions at the injection site as well as systemic reactions were monitored for 28 days in the group that received the simultaneous administration, and for 14 days after each injection in the sequential group.
The population in which safety was assessed consisted of participants who received a minimum of 1 dose of the vaccine. In the sequential group, 2 patients were excluded from the evaluation of adverse events because of the reasons below.1 patient: eligibility error, 1 patient: discontinued intervention (patient's decision) Regarding pain of axilla (evaluated only patients who received pneumococcal vaccine), additional 2 patients were excluded because they did not receive pneumococcal vaccine.
|
|
Skin and subcutaneous tissue disorders
Pain of axilla
|
4.9%
4/81 • Local reactions at the injection site as well as systemic reactions were monitored for 28 days in the group that received the simultaneous administration, and for 14 days after each injection in the sequential group.
The population in which safety was assessed consisted of participants who received a minimum of 1 dose of the vaccine. In the sequential group, 2 patients were excluded from the evaluation of adverse events because of the reasons below.1 patient: eligibility error, 1 patient: discontinued intervention (patient's decision) Regarding pain of axilla (evaluated only patients who received pneumococcal vaccine), additional 2 patients were excluded because they did not receive pneumococcal vaccine.
|
5.2%
4/77 • Local reactions at the injection site as well as systemic reactions were monitored for 28 days in the group that received the simultaneous administration, and for 14 days after each injection in the sequential group.
The population in which safety was assessed consisted of participants who received a minimum of 1 dose of the vaccine. In the sequential group, 2 patients were excluded from the evaluation of adverse events because of the reasons below.1 patient: eligibility error, 1 patient: discontinued intervention (patient's decision) Regarding pain of axilla (evaluated only patients who received pneumococcal vaccine), additional 2 patients were excluded because they did not receive pneumococcal vaccine.
|
Additional Information
Kei Nakashima, Associate Chief
Department of Pulmonary Medicine, Kameda Medical Center
Phone: 81-4-7092-2211
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place